There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual property rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.
This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Funding: Preparation of this manuscript received financial support from the WHO-sponsored African AIDS Vaccine Program based in Geneva, Switzerland. The AAVP-ELH Working Group is an expert ethical advisory body to AAVP, established to provide independent advice to AAVP through WHO/IVR/HVI regarding the development plan of AAVP research ethics. WHO/IVR/HVI and WHO/AFRO/ATM also provide secretarial and administrative support to AAVP. The above financial support notwithstanding, the views expressed are those of the author and do not represent the views of any of the organisations listed above.
Competing interests: None.
Read the full text or download the PDF:
Other content recommended for you
- Are pharmaceutical patents protected by human rights?
- Stored human tissue: an ethical perspective on the fate of anonymous, archival material
- Intellectual property rights and detached human body parts
- Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees?
- The human body as property? Possession, control and commodification
- The COVID-19 vaccine patent: a right without rationale
- Is the commercialisation of human tissue and body material forbidden in the countries of the European Union?
- Don’t worry about the drug industry’s profits when considering a waiver on covid-19 intellectual property rights
- Patent wars: affordable medicines versus intellectual property rights
- India must respect intellectual property rights, report says